Identity
- Trade Name
- iBEAM evo CT Overlay RT EUDAMEDiBEAM® FDA UDI
- Generic Name
- Basic diagnostic x-ray system table, non-powered FDA UDI
- Device Name
- iBEAM evo CT Overlay EUDAMEDiBEAM evo CT Overlay RT is intended to support the patient during CT and PET CT imaging procedures for radiation therapy applications. FDA UDI
- Model / Reference
- P10105-183 EUDAMEDFDA UDI
- Description
- iBEAM evo CT Overlay RT is intended to support the patient during CT and PET CT imaging procedures for radiation therapy applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056719002237 EUDAMEDFDA UDI
- Basic UDI-DI
- 04056719BUDI0000000004J2 EUDAMED
- Direct Marketing DI
- 04056719002237 EUDAMED
- FDA Product Code
- IXQ FDA UDI
- EMDN Code
- Z11010480 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Basic diagnostic x-ray system table, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1980 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iBEAM evo CT Overlay RT by 3C-Medical Intelligence GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 04056719BUDI0000000004J2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3C-Medical Intelligence GmbH
- EUDAMED SRN
- DE-MF-000023763
Sources (2)
- EUDAMED 0b00df0e-4027-4bd5-bd1d-a4281f8a8f51 61 fields · synced Jul 15, 2026
- FDA UDI b31959c7-dbc0-46fe-a8d8-9061152eed51 34 fields · synced May 30, 2026